NCT01841996

Pharmacokinetics and Safety Study of ME1111 in Moderate to Severe Onychomycosis Patients

A Phase 1 Randomized, Double-Blind, Vehicle-Controlled, Multiple-Dose Study of the Safety, Absorption and Systemic Pharmacokinetics of ME1111 Topical Agent Applied to All Toenails of Adult Moderate to Severe Onychomycosis Patients for 28 Days

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Meiji Seika Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is Randomized, Double-Blind, Vehicle-Controlled, Multiple-Dose Study. The purpose is to determine the safety, tolerability, systemic exposure and pharmacokinetics of ME1111 after repeated daily topical application of ME1111 in a maximal use setting in adults with distal subungual onychomycosis of the toenails.

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DRUG	ME1111 solution	Once a day for 28 days
DRUG	Vehicle Solution	Once a day for 28 days

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-08-01
• First posted: 2013-04-29
• Last updated: 2013-12-17

Locations

2 sites across 1 country: United States